Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

September 9, 2026 updated by: EMD Serono Research & Development Institute, Inc.

An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)

The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • Camperdown, Australia
        • Chris O'Brien Lifehouse
      • Kogarah, Australia
        • St George Private Hospital
      • Liverpool, Australia
        • Liverpool Hospital - PARENT
  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc - STL
      • Leuven, Belgium
        • UZ Leuven
  • Denmark
      • Aalborg, Denmark
        • Ålborg Universitets Hospital - PARENT
      • Copenhagen, Denmark
        • Rigshospitalet
      • Odense, Denmark
        • Sjaellands Universitetshospital - other
  • France
      • Angers, France
        • ICO - Site Paul Papin - service d'oncologie medicale
      • Caen, France
        • Centre Francois Baclesse - Service d'Oncologie Medicale
      • Lille, France
        • Centre Oscar Lambret - service de cancerologie gynecologique
      • Lyon, France
        • Centre Leon Berard - Service d'Oncologie Medicale
      • Paris, France
        • Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
      • Paris, France
        • Hôpital Cochin - Hematologie et Oncologie Médicale
      • Paris, France
        • Hopital Tenon - service d'oncologie medicale
      • Paris, France
        • Hôpital Européen Georges Pompidou - Hématologie Oncologie
      • Paris, France
        • Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud - service d'oncologie medicale
      • Strasbourg, France
        • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
      • Strasbourg, France
        • Centre de Radiotherapie Clinique Sainte Anne - 300207251
      • Villejuif, France
        • Institut Gustave Roussy - Oncologie Médicale
  • Germany
      • Berlin, Germany
        • Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie
      • Bonn, Germany
        • Universitaetsklinikum Bonn AoeR - Frauenklinik
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde
      • Essen, Germany
        • Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde
      • Münster, Germany
        • Universitaetsklinikum Muenster - Parent
      • Münster, Germany
        • Universitätsklinikum Münster - Gynecology
      • Regensburg, Germany
        • Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie
      • Tübingen, Germany
        • Universitaetsklinikum Tuebingen - Parent
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • The Lady Davis Carmel Medical Center
      • Jerusalem, Israel
        • Shaare Zedek
      • Jerusalem, Israel
        • Hadassah University Hospital - Ein Kerem
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
      • Bologna, Italy
        • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola - SSD Oncologia Medica Zamagni
      • Catania, Italy
        • Osp Cannizzaro Catania
      • Catanzaro, Italy
        • Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico
      • Milan, Italy
        • IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica
      • Milan, Italy
        • Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
      • Naples, Italy
        • Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology
      • Padova, Italy
        • IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica
      • Roma, Italy
        • Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
      • Rome, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis Eindhoven - Parent
  • Poland
      • Bydgoszcz, Poland
        • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy - Dept of Chemotherapy
      • Gdynia, Poland
        • Szpitale Pomorskie spó
      • Krakow, Poland
        • Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada
      • Lodz, Poland
        • Instytut MSF Sp.z.o.o
      • Otwock, Poland
        • Europejskie Centrum Zdrowia - Oddzial Onkologii
      • Torun, Poland
        • MICS Centrum Medyczne Torun - Medicovernn
  • Spain
      • Badalona, Spain
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron - Oncology Dept.
      • Barcelona, Spain
        • Hospital Clinic de Barcelona - Servicio de Oncologia
      • Girona, Spain
        • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre - Servicio de Oncologia
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal - Servicio de Oncologia
      • Madrid, Spain
        • Clinica Universidad de Navarra (MAD) - Oncology Service
      • Málaga, Spain
        • Hospital Regional Universitario de Malaga - Oncology Dept
  • Switzerland
      • Bellinzona, Switzerland
        • Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann
      • Frauenfeld, Switzerland
        • Kantonsspital Frauenfeld - 150509250
      • Liestal, Switzerland
        • Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie
      • Sankt Gallen, Switzerland
        • Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie
      • Zurich, Switzerland
        • Universitaetsspital Zuerich - Klinik fuer Gynaekologie
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital - Dept of Oncology
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre - Dept of Medical Oncology
      • Guildford, United Kingdom
        • Royal Surrey County Hospital - Dept of Oncology
      • Leeds, United Kingdom
        • St James's University Hospital - Dept of Oncology
      • London, United Kingdom
        • University College London Hospitals - NIHR/Wellcome Trust
      • London, United Kingdom
        • Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
      • London, United Kingdom
        • Guy's Hospital - Dept of Medical Oncology
      • Manchester, United Kingdom
        • The Christie Hospital - Dept of Oncology
      • Northwood, United Kingdom
        • Mount Vernon Hospital - Dept of Oncology
      • Sutton, United Kingdom
        • Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • San Francisco, California, United States, 94158
        • University of California San Francisco - UCSF Medical Center
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Fairfax, Virginia, United States, 22031
        • Next Oncology - Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent.
  • Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening.
  • Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be >6 months, with documented disease progression prior to study entry).

OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)

  • Intolerant to standard of care treatment options or refused standard of care treatment or the participant's treating physician considers that the lack of standard of care treatment is not detrimental for the participant.
  • Measurable disease per RECIST v1.1, as assessed by Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
  • Other Protocol defined inclusion criteria could apply.

Exclusion Criteria:

  • Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the platinum administration in either the first or second-line setting.
  • History of additional malignancy within 3 years before the date of enrollment.
  • Known brain metastases, unless clinically stable, that is without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration.
  • Active and/or uncontrolled infection.
  • History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
  • Organ transplantation, including allogenic stem cell transplant.
  • Patients with history of drug-induced severe cutaneous adverse reaction (SCAR; including but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], or drug reaction with eosinophilia and systemic symptoms [DRESS]), or dose-limiting immune-mediated reactions related to skin.
  • Other Protocol defined exclusion criteria could apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A, Arm 1: Tuvusertib with Niraparib
In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
Drug: Tuvusertib (M1774)
Tuvusertib will be administered orally.
Other Names:
  • M1774, VXc-400, VRT-1363004, substance code MSC2584415A
Drug: Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Other Names:
  • GSK3985771, MK-4827
Experimental: Part A, Arm 2: Tuvusertib with Lartesertib
In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
Drug: Tuvusertib (M1774)
Tuvusertib will be administered orally.
Other Names:
  • M1774, VXc-400, VRT-1363004, substance code MSC2584415A
Drug: Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Other Names:
  • M4076, substance code MSC2585823A
Experimental: Part B (dose optimization), dosing regimen 1 :Tuvusertib+Niraparib or Tuvusertib +Lartesertib
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Drug: Tuvusertib (M1774)
Tuvusertib will be administered orally.
Other Names:
  • M1774, VXc-400, VRT-1363004, substance code MSC2584415A
Drug: Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Other Names:
  • GSK3985771, MK-4827
Drug: Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Other Names:
  • M4076, substance code MSC2585823A
Experimental: Part B (dose optimization), dosing regimen 2: Tuvusertib + Niraparib or Tuvusertib + Lartesertib
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Drug: Tuvusertib (M1774)
Tuvusertib will be administered orally.
Other Names:
  • M1774, VXc-400, VRT-1363004, substance code MSC2584415A
Drug: Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Other Names:
  • GSK3985771, MK-4827
Drug: Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Other Names:
  • M4076, substance code MSC2585823A
Experimental: Part B: Tuvusertib Monotherapy
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Drug: Tuvusertib (M1774)
Tuvusertib will be administered orally.
Other Names:
  • M1774, VXc-400, VRT-1363004, substance code MSC2584415A

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
Time Frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Time Frame: Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years
Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A and Part B: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Time Frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part A and Part B: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Time Frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Part B: Overall Survival
Time Frame: Time from date of randomization to death, approximately 3.5 years
OS is defined as the time from randomization to death due to any cause.
Time from date of randomization to death, approximately 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EMD Serono Research & Development Institute, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck KGaA, Darmstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS201924_0002
  • 2024-511202-23-00 (Other Identifier: EU trial number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD supporting publicly available results will be evaluated for sharing.

IPD Sharing Time Frame

IPD from completed trials will be publicly available within 6 months after all of the following events:

  • Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions
  • Public results via primary manuscript or trial registry disclosure
  • Legal authority to share data
  • Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21

IPD Sharing Access Criteria

Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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